XFT Medical G3 Series User manual

User Manual
Thanks for buying our product, please read the user manual carefully before use and keep it properly.
Date: July 15, 2019
No.: XFT-2001D-A(G)
Rev. C1
Manufacturer: Shenzhen XFT Medical Limited
Add: Room 203, Building 1, Biomedicine Innovations Industrial Park,
#14 Jinhui Road, Pingshan District, Shenzhen, China
Tel: [phone] Fax: [phone]
Web: www.xft-china.com Mail: [e-mail]
ShangHai International Holding Corp.GmbH (Europe)
Eiffestrasse 80 D-20537 Hamburg Germany.
Foot Drop System
G3
Product Name: Nerve and Muscle Stimulator
Model: XFT-2001D

Contents
1
5
8
10
11
12
13
13
5
15
16
17
18
19
11
7
5
6
7
9
For Your Health and Safety
Introduction to Your XFT-2001D
1.Introduction
2. Intended Use
3. Functions and Features
Components of Your XFT-2001D
1. Components
2. Stim Unit & Cuff
3. Quick-fit Electrode
4. Remote Control
Daily Use of Your XFT-2001D
1. Charging for Stim Unit and Remote Control
2. Use with Quick-fit Electrode or Gel Electrode
3. Wear the Product
4. Remove the Product
Gait Mode
Training Mode
Care and Maintenance
Frequently Asked Questions
Specifications
Configurations
14
Steps for Use
21
Electromagnetic Compatibility (EMC)
Packing & Shipping Requirements
Warranty
22
28
29

Directions for Use
1
For Your Health and Safety
Contraindications
Do not use on persons with implanted demand-type cardiac pacemakers or defibrillators.
Do not place the electrodes over malignant tumors.
Do not place the electrodes over areas in which symptoms of existing thrombosis is present.
Do not use if person has a history of seizure disorder.
The XFT-2001D should not be used on a leg where a regional disorder, such as fracture
or dislocation, would be adversely affected by motion from the stimulation.
The XFT-2001D should not be used on a leg where strength testing or strength training is planned.
Warnings about Functional Electrical Stimulation (FES)
WARNINGS are used to identify a hazard that may lead to death or serious injury.
The use of XFT-2001D may interfere with the proper functioning of electronic monitoring
equipment such as EKG machines. However, the operation of the XFT-2001D device will
not be affected by the use of electronic monitoring equipment.
The XFT-2001D should not be worn while receiving an MRI scan.
The use of electrodes not supplied by XFT, may diminish results or increase risk of burns or
discomfort. Do not place electrodes over open wounds, broken skin or metal objects
beneath the skin, such as surgical staples.
List of Symbols
Contraindications
User must comply with the instructions
Type BF Equipment
Caution
Declaration of conformity according to the applicable
European directives
Declaration of conformity according to the applicable
European directives and the number of the notified body (0123)
European Authorized Representative
Date of Manufacturer
Manufacturer
Warranty Card
Product name: Model no.:
Purchase date:
Buyer'sinformation:
Distributor's information:
Product serial no.:
Distributor Seal:
Manufacturer: Shenzhen XFT Medical Limited
Add: Room 203, Building 1, Biomedicine Innovations Industrial Park,
#14 Jinhui Road, Pingshan District, Shenzhen, China
Tel: [phone] Web: www.xft-china.com Mail: [e-mail]

2
Care should be taken while using XFT-2001D therapy in close proximity (e.g. less than 1 meter)
to devices which emit radio frequencies such as cellular phones or two-way radios, as some
types of transmitters may cause undesirable stimulation to the user.
External defibrillation of a person wearing an FES device can damage the device or injure
the patient even when the device is turned off. Under some circumstances, there may be
risk of burns under the electrode sites during defibrillation. To eliminate any risk, the FES
electrodes should be removed before defibrillation paddles are applied.
Effects of long-term chronic stimulation are unknown in this particular application.
Specific Warnings
Care should be taken when using the XFT-2001D for people who experience dizziness or
have difficulty maintaining balance. The XFT-2001D is not designed to prevent from falling.
The user should follow doctor's advice to relocate the position of the electrodes within the cuff.
Do not use the XFT-2001D without electrodes.
Never use the XFT-2001D on any area of the body other than the leg.
Stop using the XFT-2001D if stimulation does not come on at the appropriate time when
walking and/or there is a change in the sensation perceived while the stimulation is on.
XFT-2001D is not intended for use around flammable environments.
Care should be taken to minimize excessive impact to the XFT-2001D Control Module.
This includes standing or kneeling on the unit, or impact from any hard surfaces.
The FES cuff should not be worn over swollen, infected or inflamed areas or skin eruptions
such as phlebitis, thrombophlebitis and varicose veins.
Precautions: Used to identify a hazard that may result in minor or moderate injury to
the user or patient or damage to the equipment or other property.
Inflammation in the region of the FES cuff may be aggravated by motion, muscle activity, or pressure
from the FES cuff. Advise patients to stop using the XFT-2001D until any inflammation is gone.
After removing FES cuff, it is normal for the areas under the electrodes to be red and indented.
The redness should disappear in approximately one hour. Persistent redness, lesions or
blisters are signs of irritation. Use of the XFT-2001D should be temporarily halted until any
inflammation is resolved completely.
The safety of XFT-2001D for use during pregnancy has not been established.
Do not use simultaneously with high frequency hospital equipment (e.g. diathermy equipment).
It may result in burns at the site of the stimulator electrodes and possible damage to the stimulator.
Improper or prolonged use of electrodes may result in increased risk of skin irritation or burns
and decreased effectiveness. Infrequently, an allergic response to the electrode adhesive or gel
may occur. Do not place electrodes on skin which is already irritated, as this will increase the
risk of discomfort with stimulation or skin burns.
As a FES device, XFT-2001D should be used by the patient after consulting a physician or a
qualified clinician.
Directions for Use
Warranty Statement
1. The XFT-2001D Foot Drop System is provided with one year warranty starting from the
date of purchasing.
2. We will not provide free repair for the malfunctions caused by the following behaviors.
a) Disassemble or modify the product without authorization.
b) Accidentally blow or drop the product during use or transportation.
c) Lack of reasonable maintenance.
d) Operate not according to the instruction.
e) Repaired by unauthorized repair store.
3. When asking for guarantee service, please take with the guarantee card.
Note: It is charged according to the stipulation for the repair service out of the warranty.
29

3
Should any technical problems occur that is not covered in this guide, contact Shenzhen
XFT Medical Limited, Do not attempt to repair the XFT-2001D.
The FES cuff is only to be worn on the leg of the patient for whom it is fitted. It should not
be worn by anyone else or any other part of the body.
Turn off the XFT-2001D before putting on the FES cuff. Do not turn on the XFT-2001D until
the FES cuff is fastened in place.
Medical electrical equipment needs special precautions for electromagnetic compatibility.
Use caution in applying electrical stimulation to persons suspected of having heart disease.
More clinical data is needed to show that such persons will not experience adverse results.
Use caution when p la ci ng e le ct rodes o n a reas o f t he skin wi th r ed uced r es ponse to
normal sensory stimuli, due to the risk of skin burns.
XFT-2001D devices should be kept out of the reach of children.
Use caution in applying electrical stimulation to persons suspected of having epilepsy. More
clinical data is needed to show that such a person will not experience adverse events.
Do not use XFT-2001D following recent surgery where muscle contraction may disrupt the
healing process.
Do not use lotion or oil in the area that the electrodes make contact with the skin. Stimulation
may not be effective.
The safety and efficiency of XFT-2001D depends on the proper use and handling of the
stimu la tor. Improper use of the device or electrodes can result in injury to the patient.
Regularly check accessories for wear and replace as needed. Electrodes should be firmly
secured to the skin.
Never use the XFT-2001D if it appears to be malfunctioning. If there is a change in the
way it usually works (i.e. change in sensation, surging of stimulation, intermittent stimulation)
do not use the XFT-2001D and contact your clinician immediately.
The XFT-2001D should be used with electrodes supplied by Shenzhen XFT Medical Limited.
Adult supervision and assistance should be provided for anyone needing help while using the
XFT-2001D system.
Protect all electronic components from contact with water, such as from sinks, bathtubs,
shower stalls, rain, snow, etc.
Patients should not wear the XFT-2001D during x-ray examinations.
Specific physician clearance should be obtained before using the XFT-2001D on the patients who
have an alteration of normal arterial or venous flow in the region of the FES cuff because of local
insufficiency, occlusion, arteriovenous fistula for the purpose of hemodialysis or a primary disorder
of the vasculature.
Specific physician clearance should be obtained before using the XFT-2001D when
patients have a structural deformity in the area to be stimulated.
Skin problem where the FES cuff is worn may be aggravated by the XFT-2001D.
Turn off the XFT-2001D before removing or replacing the electrodes.
Directions for Use
Manufacturer: Shenzhen XFT Medical Limited
Add: Room 203, Building 1, Biomedicine Innovations Industrial Park,
#14 Jinhui Road, Pingshan District, Shenzhen, China
Date-Month-Year
Temperature range: -20℃-55℃
Relative humidity range: ≤93% (Non-condensing)
Atmospheric pressure: 70kPa-106kPa
28

4
ADVERSE REACTIONS
In the unlikely event that any of the following occurs, advise patient to stop using the
XFT-2001D immediately and consult his/her physician:
– Signs of significant irritation or pressure sores where the FES cuff contacts the skin
– A significant increase in muscle spasticity
– A feeling of heart related stress during stimulation
– Swelling of the knee, leg, ankle or foot
– Any other unanticipated reaction
Skin irritations and burns have been reported with the use of powered muscle stimulators.
Skin irritation and burns beneath the electrodes have been reported with the use of surface functional
electrical stimulation devices. Do not leave the electrodes in place for long periods of time without
checking or cleaning the skin underneath them. It is normal to observe slightly reddened areas under
the electrode placement. However, the redness should disappear within an hour. Signs of irritation
are maintained redness, small pimple-like lesions or blisters. DO NOT continue stimution over
irritated skin.
Notify the medical doctor if these conditions persist and discontinue the use of the XFT-2001D until
the problem is solved.
Cautions
ALWAYS use the XFT-2001D under specific instruction of a qualified clinician.
NEVER use the XFT-2001D in a situation where an unexpected or unusual stimulus may occur,
such as driving or operating motorized equipment.
NEVER use the XFT-2001D unit with frayed or broken leads.
ALWAYS handle the unit carefully. DO NOT expose the unit to water, excessive heat or vibration.
DO NOT place electrodes anywhere other than below the knee on the leg for which the XFT-2001D
is prescribed.
AVOID dropping the XFT-2001D. Although robustly designed, damage may occur that could cause
the unit to malfunction.
DONOTopentheunit.TheXFT-2001Dhasnouserorclinician serviceable parts inside the control
module enclosure.
TURN OFF the unit if sitting for an extended period of time.
The stimulator should not be used while operating potentially dangerous equipment such as
automobiles, power lawn mowers or large machinery. Abrupt changes in stimulation level could
create a hazard.
The XFT-2001D should not be worn or used while sleeping or bathing.
The use of heat or cold producing devices such as electric blankets, heating pads or ice
packs may affect the electrodes or the person's circulation and increase the risk of injury.
A medical doctor and clinician should be consulted before using with XFT-2001D.
Medical electrical equipment needs special precautions for electromagnetic compatibility.
This product conforms to standards IEC60601-1-2 of EMC.
27
Directions for Use
Recommended separation distance between portable and mobile
RF communications equipment and the Nerve and Muscle Stimulator
The device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the Nerve and Muscle Stimulator
as recommended below, according to the maximum output power of the communications
equipment.
This device can be used under the environment that radiated RF disturbances are controlled.
User should maintain a minimum distance between portable and mobile RF communications
equipment to prevent electromagnetic interference. Following recommended distance is
calculated according to the maximum output power of the communication equipment.
Rated maximum output
power of transmitter (W)
Separation distance according to frequency of transmitter (m)
150kHz -80MHz
d=1.2 P
80MHz -800MHz
d=1.2 P
800MHz -2.7GHz
d=2.3 P
0.01
0.1
1
10
100
0.12
0.38
1.2
3.79
12
0.12
0.38
1.2
3.79
12
0.23
0.73
2.3
7.27
23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance “d” in meters can be estimated using the equation applicable to the
frequency of transmitter, where “P” is the maximum output power rating of the transmitter
in watts according to the transmitter manufacturer.
Note1: At 80M and 800MHz, the separation distance for the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and refection from structures, objects and people.
Table 5

5
1. Introduction
Introduction to Your XFT-2001D
XFT-2001D Foot Drop System is an advanced functional electrical stimulation (FES) device
which brings remarkable effect on foot drop patient. Dropped-foot patient due to central nervous
system injuries, such as Stroke, Incomplete Spinal Cord Injury, Traumatic Brain Injury, Cerebral
Palsy, Multiple Sclerosis may benefit from the device.
XFT-2001D Foot Drop System adopts advanced MEMS sensor technology and intelligent
algorithms, precisely controlling the time and duration of electrical stimulation by tracking the
swing angle and pace of patient's leg. XFT-2001D delivers electrical pulses to the common
peroneal nerve as well as the tibialis anterior and other muscles to make the movement of
dorsi fl exion and e ve rs ion. Those mil d el ec trica l pulses stimulate patient's leg muscles,
making them lift the foot at an appropriate phase while walking and therefore enabling patient
to walk more steadily, naturally and safely.
How does XFT-2001D Foot Drop System work?
Built-in gyroscope
and accelerometer Stimulation on Stimulation off
Common peroneal nerve
Normal Foot
Drop Foot
Dorsiflexion
Electrical
Stimulation
When the leg swings to the angle of threshold, the electrical stimulation will be triggered.
2. Intended Use
For rehabilitation and walking aids of foot drop patients due to stroke or other central nervous
system injuries.
Please use the Foot Drop System patient kit under the recommendation of a doctor or physician.
26
Directions for Use
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless
communications equipment
Test
frequency
(MHZ)
a)
Band
(MHZ)
a)
Service b) Modulation Maximum
power(W)
Distance
(m)
IMMUNITY
Test Level
(V/m)
385 380-390 TETRA 400
b)
Pulse modulation
18 Hz 1.8 0.3 27
450 430-470 GMRS 460.
FRS 460
c)
FM
± 5kHz deviation
1 kHz sine
20.3 28
704-787 LTE Band 13,
17
b)
Pulse modulation
217 Hz 0.2 0.3 9
800-960
710
745
780
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 85,
LTE Band 5
b)
Pulse modulation
18 Hz 20.3 28
810
870
930
1720
1845
1970
1700-1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3, 4, 25; UMTS
b)
Pulse modulation
217 Hz 20.3 28
2450 2400-2570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
b)
Pulse Modulation
217 Hz 20.3 28
5240
5500
5785
5100-5800 WLAN 802.11
a/n
b)
Pulse Modulation
217 Hz 20.3 9
NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the
transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m.
The 1 m distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used
because while it does not represent actual modulation, it would be worst case.
Table 4

3. Functions and Features
Bluetooth 4.0, more stable and reliable data transmission, easy operation and setting.
Thin and light Stim Unit & Cuff with patented design, easy and simple to wear.
OLED screen on remote control.
Auto off in low voltage or after 30 minutes of standby.
Gait and training mode for choice.
6
25
Directions for UseDirections for Use
Note1: At 80MHz and 800MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and refection from structures, objects and people.
a) The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz
are 6.765 MHz to6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz;
and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz
are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz,
10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz,21.0 MHz
to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
b) Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which this is used exceeds the
applicable RF compliance level above, this should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating.
c) Field strengths should be less than 3V/m in the frequency range of 150k~80MHz.

Components of Your XFT-2001D
1. Components
XFT-2001D Foot Drop System patient kit mainly consists of the following parts:
Stim unit & Cuff Quick-fit Electrode
Remote Control
Power Adapter
Gel Electrode
24
Directions for UseDirections for Use
Guidance and manufacture's declaration – electromagnetic
immunity
This equipment should be used in the electromagnetic environment specified below.
User should assure that it is used in such an environment.
Immunity test IEC60601 test level Compliance
level
Electromagnetic
environment - guidance
Conducted RF
IEC 61000-4-6
3Vrms
150 kHz to 80 MHz
AM 80% 1kHz
Modulation, step1 %
Dwell time 1s
3Vrms
6Vrms
in ISM and amateur
radio bands between
150 kHz and 80 MHz (a)
6Vrms
Radiated RF
IEC 61000-4-3
10 V/m
80MHz to 2.7GHz
AM 80% 1kHz
Modulation, step1 %
Dwell time 1s
10 V/m
Portable and mobile RF
communications equipment
should be used no closer to
any parts than the recommended
separation distance that
calculated from the equation
applicable to the frequency
of the transmitter.
Recommended separation
distance:
d=1.2 P 150 kHz to 80 MHz
d=1.2 P 80MHz to 800 MHZ
d=2.3 P 800MHz to 2.7GHz
d=6 P/E
at RF wireless communications
equipment bands (Portable RF
communications equipment
(including peripherals such as
antenna cables and external
antennas) should be used no
closer than 30 cm (12 inches)
to any part of the device).
Where “P” is the maximum
output power rating of the
transmitter in watts according
to transmitter manufacturer
and “d” is the recommended
separation distance in meters.
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey (b),
should be less than the
compliance level in each
frequency range (c).
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Table 3

L
8
2. Stim Unit & Cuff
Stim Unit
Power button: press and hold for 1 second to turn on the stim unit, and the indicator turns
green. Press and hold for 1 second again to turn it off.
L/R label: L is for left leg, R is for right leg.
Micro USB port: for device charging. It needs to charge for about 3 hours when completely
drained of power. It is designed to work for 10 hours with a full charge.
Snap button: for connection between stim unit and electrode.
Cuff
Cuff: to fix the stim unit on the leg
Magnetic buckle: to fix the cuff around the leg with
one-handed operation.
Location label: to place the location mark under the
knee and align it with the tibia.
Velcro: to fix the stim unit on the cuff.
Generally, the location label
should be aligned with the tibia.
tibia
Location label
Stim unit is at the
lower medial leg
Magnetic
buckle
Location label Velcro
Magnetic buckle
snap button
Micro USB port
Power button
L/R label
23
Directions for UseDirections for Use
Guidance and manufacture's declaration – electromagnetic immunity
This equipment is intended for use in the electromagnetic environment specified below. User
should assure that it is used in such an environment.
Immunity test IEC60601 test level Compliance level Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8kV contact
±2kV, ±4kV, ±8kV,
±15kV air
±8kV contact
±2kV, ±4kV, ±8kV,
±15kV air
Floors should be wood,
concrete or ceramic tile.
Humidity should be at
least 30% if it is synthetic
materials.
Electrical fast
transients/bursts
(EFT)
IEC 61000-4-4
±2kV
100kHz repetition
frequency
±2kV
100kHz repetition
frequency
Main power quality should
be that of a typical
commercial or hospital
environment.
Surges
IEC 61000-4-5
±0.5kV, ±1kV
line-to-line
±0.5kV, ±1kV, ±2kV
line-to-ground
±0.5kV, ±1kV
line-to-line
±0.5kV, ±1kV, ±2kV
line-to-ground
Voltage dips
IEC 61000-4-11
0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270°
and 315°
0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270°
and 315°
0 % UT; 1 cycle
and
70 % UT; 25/30 cycles
Single phase: at 0°
0 % UT; 1 cycle
and
70 % UT; 25/30 cycles
Single phase: at 0°
Voltage
interruptions
IEC 61000-4-11
0% UT; 250/300 cycle 0% UT; 250/300 cycle
Mains power quality should
be typical commercial or
hospital environment. UPS
power is recommended if
this device needs to be
used continuously.
RATED power
frequency
magnetic fields
IEC 61000-4-8
30A/m
50Hz or 60Hz
30A/m
50Hz or 60Hz
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: UT is the A.C. mains voltage prior to application of the test level.
Table 2